CN104271119B - 用于稳定干燥的生物材料的方法和组合物 - Google Patents

用于稳定干燥的生物材料的方法和组合物 Download PDF

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Publication number
CN104271119B
CN104271119B CN201380023800.9A CN201380023800A CN104271119B CN 104271119 B CN104271119 B CN 104271119B CN 201380023800 A CN201380023800 A CN 201380023800A CN 104271119 B CN104271119 B CN 104271119B
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solution
drying
activity
biopharmaceutical agents
preparation
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Expired - Fee Related
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English (en)
Chinese (zh)
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CN104271119A (zh
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H·克兰
简-皮埃尔·阿莫瑞杰
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STAAT DER NEDERLANDEN VERT DOO
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STAAT DER NEDERLANDEN VERT DOO
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • A61K39/125Picornaviridae, e.g. calicivirus
    • A61K39/13Poliovirus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/12Viral antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02Inorganic compounds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N7/00Viruses; Bacteriophages; Compositions thereof; Preparation or purification thereof
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2770/00MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA ssRNA viruses positive-sense
    • C12N2770/00011Details
    • C12N2770/32011Picornaviridae
    • C12N2770/32611Poliovirus
    • C12N2770/32634Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein
    • YGENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02ATECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Virology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Biochemistry (AREA)
  • Mycology (AREA)
  • Wood Science & Technology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Inorganic Chemistry (AREA)
  • Molecular Biology (AREA)
  • Biotechnology (AREA)
  • Biomedical Technology (AREA)
  • General Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
CN201380023800.9A 2012-03-05 2013-03-05 用于稳定干燥的生物材料的方法和组合物 Expired - Fee Related CN104271119B (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261606577P 2012-03-05 2012-03-05
US61/606,577 2012-03-05
EP12158086.4 2012-03-05
EP12158086 2012-03-05
PCT/NL2013/050139 WO2013133702A1 (en) 2012-03-05 2013-03-05 Methods and compositions for stabilizing dried biological materials

Publications (2)

Publication Number Publication Date
CN104271119A CN104271119A (zh) 2015-01-07
CN104271119B true CN104271119B (zh) 2018-07-10

Family

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CN201380023800.9A Expired - Fee Related CN104271119B (zh) 2012-03-05 2013-03-05 用于稳定干燥的生物材料的方法和组合物

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Country Link
US (2) US9827303B2 (enrdf_load_stackoverflow)
EP (1) EP2822540B1 (enrdf_load_stackoverflow)
JP (1) JP6253161B2 (enrdf_load_stackoverflow)
KR (1) KR102108876B1 (enrdf_load_stackoverflow)
CN (1) CN104271119B (enrdf_load_stackoverflow)
AU (1) AU2013228096B2 (enrdf_load_stackoverflow)
BR (1) BR112014020930A2 (enrdf_load_stackoverflow)
CA (1) CA2865551C (enrdf_load_stackoverflow)
IN (1) IN2014MN01714A (enrdf_load_stackoverflow)
WO (1) WO2013133702A1 (enrdf_load_stackoverflow)
ZA (1) ZA201407198B (enrdf_load_stackoverflow)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104274827B (zh) * 2013-07-01 2020-07-14 上海贺普药业股份有限公司 贺普拉肽的制剂
US10538785B2 (en) 2013-12-23 2020-01-21 Renaud Vaillant Lyophilized lentiviral vector particles, compositions and methods
CA3027454A1 (en) * 2016-06-16 2017-12-21 Janssen Vaccines & Prevention B.V. Hiv vaccine formulation
EP3586905B1 (en) * 2017-02-24 2023-07-26 Hisamitsu Pharmaceutical Co., Inc. Method for producing microneedle device
US20200085941A1 (en) * 2017-04-28 2020-03-19 Universal Stabilization Technologies, Inc. Antigenic thermostable polio vaccines & related methods
US11400051B2 (en) * 2017-07-11 2022-08-02 Universal Stabilization Technologies, Inc. Method for preserving biopharmaceuticals
CN111166891B (zh) * 2018-11-13 2022-04-05 中国药科大学 甘露醇共晶辅料及其制备方法和用途
CN112111609A (zh) * 2020-10-29 2020-12-22 上海伯杰医疗科技有限公司 一种肠道病毒通用型核酸检测试剂盒
CN114748615A (zh) * 2022-04-29 2022-07-15 成都安永鼎业生物技术有限公司 一种治疗用重组卡介苗的冻干制剂及其制备方法和用途
CN115089864B (zh) * 2022-07-14 2023-12-29 复旦大学 一种使用冷冻干燥技术制备可溶性微针贴片的方法
CN116763914B (zh) * 2023-02-06 2024-02-23 广东永顺生物制药股份有限公司 猪瘟、高致病性猪繁殖与呼吸综合征二联耐热保护剂活疫苗及其制备方法
CN117482072A (zh) * 2023-11-17 2024-02-02 上海市浦东新区公利医院(第二军医大学附属公利医院) 山梨糖醇在制备治疗呼吸道合胞病毒所致疾病的药物中的应用

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4500512A (en) * 1981-05-13 1985-02-19 Institut Pasteur Stabilizing agents for live viruses for preparing vaccines, and stabilized vaccines containing said stabilizing agents

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0761955B2 (ja) * 1988-04-28 1995-07-05 国立予防衛生研究所長 凍結乾燥a型肝炎ワクチン
DK0939648T3 (da) * 1996-09-26 2008-02-11 Merck & Co Inc Rotavirusvaccineformuleringer
US6210683B1 (en) * 1997-09-05 2001-04-03 Merck & Co., Inc. Stabilizers containing recombinant human serum albumin for live virus vaccines
JP5118798B2 (ja) * 2000-03-07 2013-01-16 メルク・シャープ・エンド・ドーム・コーポレイション アデノウイルス製剤
BR0111494A (pt) * 2000-06-08 2004-01-13 Powderject Vaccines Inc Pó de livre escoamento formador de gel adequado para uso como uma vacina, processo para a preparação do mesmo, receptáculo de dosagem para uma seringa sem agulha, seringa sem agulha, composição de vacina, método para vacinação de um indivìduo, pó adequado para uso como uma vacina, e, processo para a preparação do mesmo
GB0020089D0 (en) 2000-08-15 2000-10-04 Smithkline Beecham Biolog Vaccine Composition
FR2814957B1 (fr) * 2000-10-06 2002-12-20 Aventis Pasteur Composition vaccinale et procede de stabilisation
MXPA06006947A (es) * 2003-12-17 2007-01-26 Wyeth Corp Metodos para producir virus de almacenamiento estable y composiciones inmunogenicas de estos.
DK1699919T3 (en) 2003-12-24 2017-03-20 De Staat Der Nederlanden Vertegenwoordigd Door De Mini Van Volksgezondheid Welzijn En Sport RESPIRATORY SYNCYTIAL VIRUS WITH A GENOMIC DEFICIENCY COMPLETED IN TRANS
GB0503337D0 (en) * 2005-02-17 2005-03-23 Glaxosmithkline Biolog Sa Compositions
TWI398272B (zh) * 2005-03-08 2013-06-11 Intervet Int Bv 化學定義的安定劑
MX2007015476A (es) * 2005-06-14 2008-02-25 Amgen Inc Formulaciones de proteina autoamortiguadoras.
EA036522B1 (ru) * 2009-12-11 2020-11-19 Пфайзер Инк. Фармацевтическая композиция, пригодная для лиофилизации, содержащая множество терапевтических частиц

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4500512A (en) * 1981-05-13 1985-02-19 Institut Pasteur Stabilizing agents for live viruses for preparing vaccines, and stabilized vaccines containing said stabilizing agents

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
heat stability of the lyophilized sabin poliovaccine;Hiroshi Shiomi,etal;《Jpn.J.Infect.Dis.》;20031231;70-72 *

Also Published As

Publication number Publication date
US10335479B2 (en) 2019-07-02
WO2013133702A1 (en) 2013-09-12
EP2822540B1 (en) 2020-04-08
ZA201407198B (en) 2016-02-24
AU2013228096A1 (en) 2014-09-11
US20180055924A1 (en) 2018-03-01
AU2013228096B2 (en) 2017-07-13
CN104271119A (zh) 2015-01-07
JP2015509529A (ja) 2015-03-30
BR112014020930A2 (pt) 2017-06-27
JP6253161B2 (ja) 2017-12-27
CA2865551A1 (en) 2013-09-12
KR102108876B1 (ko) 2020-05-12
KR20150008848A (ko) 2015-01-23
EP2822540A1 (en) 2015-01-14
CA2865551C (en) 2021-01-12
US20150030629A1 (en) 2015-01-29
US9827303B2 (en) 2017-11-28
IN2014MN01714A (enrdf_load_stackoverflow) 2015-05-29

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Granted publication date: 20180710